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临床试验/NCT03182036
NCT03182036已完成不适用

Portable Oxygen Concentrator Signal Capture Study

ResMed2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
ResMed
入组人数
20
试验地点
2
主要终点
Oxygenation

研究概览

简要总结

The main purpose of this study is to learn how patients breathe on portable oxygen concentrators (POCs), and to get feedback from patients using POCs.

详细描述

This study aims to examine patient oxygenation levels and markers of exertion (e.g. breath rate, heart rate and breath pattern) while using a portable oxygen concentrator, with the aim to understand exercise desaturation in hypoxemic subjects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is willing to give written informed consent
  • Patient can read and comprehend English
  • Patient is ≥ 18 years of age
  • Patient has moderate to severe hypoxaemia (SpO2 ≤ 92%) at rest
  • Patient reports shortness of breath on exertion

排除标准

  • Patient has musculoskeletal impairment, or other impairment that may be the limiting factor in 6MWT
  • Patient has a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
  • Patient has acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency
  • Patient shows signs of acute exacerbation of underlying lung condition
  • Patient is deemed to be unsuitable for inclusion in the opinion of the researcher, including for the following reasons:
  • they do not comprehend English
  • they are unable to provide written informed consent
  • they are physically unable to comply with the protocol

结局指标

主要结局

Oxygenation

时间窗: 20 minutes

SpO2 during rest and exercise using portable pulsed oxygen therapy

次要结局

  • Heart rate(20 minutes)
  • Nasal cannula pressure(20 minutes)

研究者

发起方
ResMed
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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